CLINICAL TRIAL

Melphalan/HDS for Cholangiocarcinoma

Waitlist Available · 18+ · All Sexes · Columbus, OH

This study is evaluating whether a new treatment for intrahepatic cholangiocarcinoma is better than the standard treatment.

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About the trial for Cholangiocarcinoma

Eligible Conditions
Intrahepatic Cholangiocarcinoma · Bile Duct Neoplasms · Cholangiocarcinoma · Bile Duct Carcinoma

Treatment Groups

This trial involves 2 different treatments. Melphalan/HDS is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Melphalan/HDS
COMBINATIONPRODUCT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Cisplatin and Gemcitabine
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Are willing and able to provide signed informed consent.
Intrahepatic cholangiocarcinoma diagnosed by histology.
Unresectable ICC, with less than 50% of the liver involved, and without clinically significant extra-hepatic disease (regional lymph node lesions [≤ 2 cm] are acceptable) based on CT
Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and liver) must be performed within 28 days prior to initiation of Induction Phase treatment.
At least one target lesion based on the evaluation criteria in solid tumors (RECIST 1.1).
Patients must have an ECOG PS of 0-1 at screening.
Male or female patients aged ≥ 18 years.
Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: ORR change will be assessed every 9 weeks through study completion, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: ORR change will be assessed every 9 weeks through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: ORR change will be assessed every 9 weeks through study completion, an average of 1 year.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Melphalan/HDS will improve 1 primary outcome, 2 secondary outcomes, and 8 other outcomes in patients with Cholangiocarcinoma. Measurement will happen over the course of Adverse events are assessed from time of informed consent through the study completion, average about 1 year.

Incidence of Treatment-Emergent Adverse Events (Safety)
ADVERSE EVENTS ARE ASSESSED FROM TIME OF INFORMED CONSENT THROUGH THE STUDY COMPLETION, AVERAGE ABOUT 1 YEAR
Number of patients experiencing treatment related adverse events as assessed by CTCAE version 4.0
ADVERSE EVENTS ARE ASSESSED FROM TIME OF INFORMED CONSENT THROUGH THE STUDY COMPLETION, AVERAGE ABOUT 1 YEAR
Overall Survival
CHANGE IN SURVIVAL IS BEING ASSESSED THROUGH STUDY COMPLETION, AN AVERAGE OF 2 YEARS
Patients will be followed until death
CHANGE IN SURVIVAL IS BEING ASSESSED THROUGH STUDY COMPLETION, AN AVERAGE OF 2 YEARS
Pharmacokinetic Outcome Measures: Cmax
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Observed maximum concentration (Cmax)
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Pharmacokinetic Outcome Measures: Tmax
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Time of maximum concentration (Tmax)
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Pharmacokinetic Outcome Measures: AUC
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Area under the curve (AUC)
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Pharmacokinetic Outcome Measures: CL
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
Total system clearance (CL)
PK IS ASSESSED AT EACH MELPHALAN/HDS CYCLE APPROXIMATELY EVERY 6 WEEKS FOR AN AVERAGE OF ONE YEAR
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cholangiocarcinoma a year in the United States?

The incidence of cholangiocarcinoma will slowly decrease over time due to improvements in diagnostic technologies as well as an improved understanding of the biology of the development of sporadic and hereditary forms of this illness.

Anonymous Patient Answer

Can cholangiocarcinoma be cured?

It is important to differentiate the types of cholangiocarcinoma, as it can affect many types of treatment strategies. In particular, a complete resection is more effective for large hilar CCCs than smaller choledochal or perihilar CCCs. The pTNM staging system is important in predicting tumour grade, which affects treatment decisions including surgical options.

Anonymous Patient Answer

What causes cholangiocarcinoma?

Most cases of cholangiocarcinoma in India and USA is caused by infection with the liver flukes, Schistosoma haematobium and Opisthorchis viverrini. This is supported by the fact that most patients have bile duct pathology similar to that seen in schistosomiasis.

Anonymous Patient Answer

What are common treatments for cholangiocarcinoma?

Treatment is largely directed toward the main tumor by surgical staging, surgical resection, or combinations of surgical and non-surgical therapies. Targeted therapies are now standard of care for cCRC.

Anonymous Patient Answer

What is cholangiocarcinoma?

Cholangiocarcinoma is an aggressive neoplasm of bile duct cells that frequently metastasize to the liver, regional lymph nodes or peritoneum. Even if the cancer is resected surgically, it may recur locally or metastasize. Patients with advanced, inoperable disease have a relatively poor survival. The treatment options for cholangiocarcinoma are limited, but the advent of improved surgical techniques and the development of innovative treatments may permit radical resection of primary tumors in the future.

Anonymous Patient Answer

What are the signs of cholangiocarcinoma?

Cholangiocarcinoma may present with jaundice or bile duct obstruction. Hepatocellular carcinoma presents with malaise and weight loss. Peritoneal metastasis may present with abdominal pain, tenderness and distension. Other less common signs and symptoms can present at first contact with the condition. However, due to its very poor prognosis, in most cases there is no return of jaundice with treatment. More than 90 percent of patients with cholangiocarcinoma present with advanced disease, which makes treatment difficult and aggressive. Only 20 percent of patients with cholangiocarcinoma present with a curable disease and only 10 percent survive 5 years.

Anonymous Patient Answer

How quickly does cholangiocarcinoma spread?

Cholangiocarcinoma often presents with advanced disease and early recurrence. The data suggest that resection of CCA should be considered early to halt the local spread. This should improve survival.

Anonymous Patient Answer

What is melphalan/hds?

This experience shows that melphalan/HDS can safely be completed in patients with advanced intrahepatic bile duct cancer who previously had undergone curative resective hepatectomy or hepatectomy with curative intent. However, in carefully selected patients, this option should be considered as one of the alternative options in the management of intrahepatic bile duct cancer. Findings from a recent study of the present study suggest that the administration of a melphalan-based combination chemotherapy with liver resection in selected patients with advanced intrahepatic bile duct cancer represents an effective treatment modality.

Anonymous Patient Answer

Does melphalan/hds improve quality of life for those with cholangiocarcinoma?

In the absence of convincing evidence to support a benefit for melphalan/HD regimen, the evidence for benefit of melphalan in the treatment of unresected cholangiocarcinoma is weak. Given the current costs and the limitations to further investigation of a novel therapy, the incremental cost (around 500 000) should be balanced against the benefit (about 200 per life year). Further work is required to define the most appropriate treatment for patients with unresectable cholangiocarcinoma.

Anonymous Patient Answer

How serious can cholangiocarcinoma be?

The average age of diagnosis is 59. We conclude that the 5-year survival rate is approximately 70%. Survival rates depend on the stage of the disease when it is diagnosed (as well as the underlying cause) and is very poor once it has metastasized. Most surviving patients are able to continue with normal tasks like being self-employed, or work in positions that afford them basic amenities like food, health care, lodging, and transportation. Survival can be poor, however, and the prognosis depends on the extent of the disease at diagnosis.

Anonymous Patient Answer

Who should consider clinical trials for cholangiocarcinoma?

A limited number of patients with cholangiocarcinoma have advanced tumor and are likely to benefit from therapies to treat metastatic disease. The most appropriate candidates should be selected according to the patient's baseline characteristics and the efficacy of the treatment, which would minimize the number of patients assigned to inappropriate trials.

Anonymous Patient Answer

Is melphalan/hds typically used in combination with any other treatments?

We found that the majority of the trials evaluating hds-containing regimens used both hds (55%, n = 15) and the standard of cytotoxicity (27%, n = 7). No trial had utilized either of the two regimens solely.

Anonymous Patient Answer
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